Implantable Bipolar Cardiac Pulse Gen

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K830390 ↗

FDA Product Code

DXY

Device Class

Class III

Regulation

21 CFR Part 870.3610

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Slimline Unipolar Endocardial Pacing Lead, 030-438

  Class III

  FDA 510(k) K865098 Active Cleared 18 Aug 1987

• Model 030-437 Implant Electrode

  Class III

  FDA 510(k) K870610 Active Cleared 20 Mar 1987

• Sterile Packaging

  Class III

  FDA 510(k) K810410 Active Cleared 5 Mar 1981

• Implantable Programmable Bipolar Cardiac (K800573)

  Class III

  FDA 510(k) K800573 Active Cleared 25 Mar 1980

• Laserpor Ap Atrial Endocard. Electr. Ld.

  Class III

  FDA 510(k) K820121 Active Cleared 12 Feb 1982

• Electrode, Model 030-324

  Class II

  FDA 510(k) K781822 Active Cleared 8 Feb 1979

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• What is the primary purpose of this device in clinical practice?

  This device is an implantable pacemaker pulse generator designed to regulate abnormal heart rhythms by delivering electrical impulses to the heart muscle. It is specifically intended for patients with bradycardia or conduction disorders, ensuring proper cardiac function through controlled stimulation of the heart.

• How is this device supplied and handled during use?

  The device is reusable as part of a pacemaker system and must be handled under sterile conditions during implantation and follow-up procedures. It is surgically implanted within the body, typically in the pectoral region, and requires careful sterile packaging and handling to maintain safety and efficacy.

• What regulatory pathway was followed for this device’s approval?

  This device was cleared through the FDA 510(k) process under Traditional Review, with a substantially equivalent determination (decision code: SESE). It falls under product code DXY and is classified as a Class III medical device, requiring compliance with strict regulatory standards for cardiac pacing applications.

• Is this device intended for single-use or can it be reused?

  This device is not single-use—it is designed as a reusable component within a pacemaker system. However, it must be handled under sterile conditions during implantation and follow-up procedures to ensure patient safety and device integrity.

• What medical specialty is primarily responsible for using this device?

  This device is categorized under Cardiovascular medical specialty, meaning it is primarily used and managed by cardiologists, electrophysiologists, or cardiac surgeons who specialize in diagnosing and treating heart rhythm disorders.